Coronary Artery Disease Clinical Trials

Cedars-Sinai Heart Institute is currently conducting the following coronary artery disease clinical trials:

CABG Outcomes:  Outcomes of Patients Undergoing Coronary Artery Bypass Graft Surgery
CDES Outcomes: Cedars-Sinai Drug Eluting Stent Outcomes  
CHAMPION PLATFORM:  A Clinical Trial Comparing Treatment with Cangrelor (in Combination with Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention
dal- OUTCOMES- A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
JOSTENT: Graftmaster Coronary Stent for Commercial Use in Selected Patients Through a Humanitarian Device Exemption (HDE)
Prognostic Significance of Circulating Endothelial Progenitor Cells (EPCs) in Patients Undergoing Primary Coronary Intervention with Drug Eluting Stent
PROTECT I: A Clinical Trial Investigating the Use of the IMPELLA® RECOVER LP 2.5 System, A Circulatory Assist Device, in Patients Undergoing High Risk PCI
REVASCULARIZE: Revascularization Comparing Surgery Versus Percutaneous Coronary Intervention for Left Main Artery Stenosis Randomized Evaluation Trial
REVITALIZE: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

CABG Outcomes:  Outcomes of Patients Undergoing Coronary Artery Bypass Graft Surgery

Principal Investigator: Raj Makkar, MD

IRB Approval Number: 6752

Contact: Michelle Domingo (310) 423- 3875

Status: Data Analysis

Summary: Cardiovascular disease remains the leading cause of mortality in the United States.  The goals of coronary artery bypass graft surgery (CABG) are to reduce symptoms associated with angina, improve quality of life of patients with symptomatic coronary artery disease (CAD), and improving long-term prognosis, including reducing the need for repeat revascularization and mortality.  The objective of this study is to study the impact of CABG in diverse real-world clinical settings and to provide objective information in patients who have undergone CABG.


CDES Outcomes: Cedars-Sinai Drug Eluting Stent Outcomes 

Principal Investigator: Rajendra Makkar, MD

IRB Approval Number: 8660

Contact: Michelle Domingo (310) 423-3875

Status: Data Analysis

Summary: The objective of this study is to evaluate the evolving practice of PCI in diverse real-world clinical settings.  The formation of this database attempts to capture both in-hospital and long-term patient outcomes retrospectively, while characterizing initial procedural strategy and outcome in great detail on the patient and lesion level, paying particular attention to the use of drug-eluting stents.  


CHAMPION PLATFORM:  A Clinical Trial Comparing Treatment with Cangrelor (in Combination with Usual Care) to Usual Care, in Subjects Who Require Percutaneous Coronary Intervention

Principal Investigator: Bruce Samuels, MD

IRB Approval Number: 11514

Contact: Michelle Domingo (310) 423-3875

Status: Follow-up

Summary: Cangrelor is an experimental drug that is being tested in this clinical trial for its ability to prevent blood clots. It may be useful in the treatment of patients with heart disease, who may be at risk of having a heart attack. The purpose of the study is to compare the effects of cangrelor with a placebo in patients having a procedure to treat the blood vessels in the heart (a percutaneous coronary intervention or PCI).  The data from this study will establish the potential for cangrelor to deliver a considerable health benefit for patients undergoing PCI, with wider implications for improving the standard of care for patients with coronary disease.  Patients with coronary atherosclerosis that need PCI (with or without a stent) can participate in this trial.


dal- OUTCOMES- A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome

Principal Investigator: Sanjay Kaul, MD

IRB Approval Number: 15648

Status: Enrolling

Contact: (310) 423-4876

Summary: This study will evaluate the potential of RO4607381 to reduce cardiovascular morbidity and mortality in stable coronary heart disease patients with recent Acute Coronary Syndrome (ACS) and evaluate the long term safety profile of the drug. Eligible patients in stable condition will be randomized to receive either RO4607381 600mg po or placebo by mouth, daily, together with a background of standard medication for ACS (including aspirin, antihypertensives and statins). The anticipated time on study treatment is 2+ years, and the target sample size is 15,600 individuals.


JOSTENT: Graftmaster Coronary Stent for Commercial Use in Selected Patients Through a Humanitarian Device Exemption (HDE)

Principal Investigator: Rajendra Makkar, MD

IRB Approval Number: 4195

Contact: Michelle Domingo (310) 423-3875

Status: Enrolling

Summary: Patients undergoing coronary angiography and who have a procedural complication of a perforation in their coronary artery can receive a JOSTENT® Coronary Stent Graft.  The JOSTENT® is a device which can close perforations in coronary arteries.  A perforation is a hole in the coronary artery wall.  Blood that feeds the heart muscle escapes through this hole and starts to fill up the sac that surrounds the heart.  A perforation can be life threatening. These perforations are rare, but are a potential complication of coronary angiography.  If this occurs, a JOSTENT® Coronary Stent Graft can be used in this life threatening situation.  The purpose of the study is to evaluate the technical success and safety of the JOSTENT Coronary Stent Graft as a life-saving treatment in cases of coronary artery perforation.  


Prognostic Significance of Circulating Endothelial Progenitor Cells (EPCs) in Patients Undergoing Primary Coronary Intervention with Drug Eluting Stent

Principal Investigator: Rajendra Makkar, MD

IRB Approval Number: 8711

Contact: Michelle Domingo (310) 423-3875

Status: Follow-up

Summary: EPCs (endothelial progenitor cells) are a type of circulating stem cell in our blood that are thought to assist in repair of the blood vessel wall. Monocytes are another type of circulating blood cell (part of the immune system). A variable number of the monocytes have a protein called Toll-like Receptor 4 (TLR4) on their surface. In this study, we will measure both of these types of cell (EPC and monocytes with TLR4) then test if there is any relationship between the number of either of these cells and patient prognosis after undergoing implantation of a coronary stent.


PROTECT I: A Clinical Trial Investigating the Use of the IMPELLA® RECOVER LP 2.5 System, A Circulatory Assist Device, in Patients Undergoing High Risk PCI

Principal Investigator: Rajendra Makkar, MD

IRB Approval Number: 10204

Contact: Michelle Domingo (310) 423-3875

Status: Data Analysis

Summary: The objective of the study is to determine if the IMPELLA® RECOVER® LP 2.5 System is safe and potentially effective for patients undergoing high risk PCI (percutaneous coronary intervention).  This investigational device pumps up to 2.5 L/min of blood from the left ventricle to systemic circulation and therefore assists the patient’s heart to circulate blood throughout their body.


REVASCULARIZE: Revascularization Comparing Surgery Versus Percutaneous Coronary Intervention for Left Main Artery Stenosis Randmized Evaluation Trial

Principal Investigator: Rajendra Makkar, MD

IRB Approval Number: 4426

Contact: Mitch Gheorghiu (310) 423-6152

Status: Enrolling

Summary: The objective of the study is to demonstrate that using PCI as a method of treatment for left main coronary artery stenosis is not statistically inferior to the gold standard open heart bypass surgery. The study population includes patients with angiographic evidence of significant narrowing of the left coronary artery. The primary end point is major adverse cardiac and cerebrovascular events at 1 year post interventional procedure. The clinical findings and periprocedural assessment of other adverse events are considered as secondary endpoints.


REVITALIZE: Randomized Evaluation of Intracoronary Transplantation of Bone Marrow Stem Cells in Myocardial Infarction

Principal Investigator: Rajendra Makkar, MD

IRB Approval Number: 4441

Contact: Michelle Domingo (310) 423-3875

Status: Enrolling

Summary: Patients who have suffered a heart attack and have undergone angioplasty and stent placement in the past 10 days may be eligible to participate in a study using their own stem cells as a potential therapy in heart muscle repair.  The use of a patient’s own bone-marrow derived stem cells may avoid the ethical and rejection issues associated with other types of stem cells. To qualify, patients must have evidence of decreased heart muscle function.  Those who participate will have cardiac MRI testing and other non-invasive evaluations and lab work at scheduled intervals up to a year. The stem cell treatment is a two-step, non-surgical procedure.  First, patients will be given local anesthesia and cells will be removed from the bone marrow.  Stem cells will then be isolated and injected into the coronary artery responsible for the heart attack.

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